Homeopathic Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs Removed from the Market Due to Reports of Anosmia
The Food and Drug Administration (FDA) issued a Warning Letter to Matrixx Initiatives, Inc. (http://www.fda.gov/ICECI/EnforcementActions/
WarningLetters/ucm166909.htm) on June 15, 2009 concerning the safety of the company's
homeopathic drugs Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs and reports of anosmia
(loss of sense of smell). These reports indicated that users experienced a long lasting or
permanent loss of smell. The immediate safety concern is the inability to detect gas leaks, fire,
or spoiled food.
In 2006, the company paid $12 million to settle lawsuits with 340 people
who suffered anosmia after using Zicam. The FDA notes in the Warning Letter that there is evidence
in the published scientific literature that various salts of zinc can damage olfactory function in
animals and humans.
Zicam Cold Remedy intranasal products are promoted as homeopathic drug
products. Homeopathy is a 19th century alternative medicine belief system in which the more dilute
the drug the more potent the product. Homeopathy has a cloudy history in U.S. drug law. The
Homeopathic Pharmacopeia was recognized in 1938 Food, Drug, and Cosmetic largely due to the efforts
of Senator Royal Copeland of New York and homeopathic physician.
The Zicam intranasal
products are labeled as containing Zincum Gluconicum 2X (zinc gluconate). The X is the Roman
numeral for 10 and 2X a 1-to-10 dilution repeated two times.
The FDA regulates homeopathic
drugs in several different ways from other drug products. Manufacturers of homeopathic drugs are
deferred from submitting New Drug Applications (NDAs) to the FDA. Homeopathic drugs are exempt from
Good Manufacturing Practice (GMP) requirements related to expiration dating and from finished
product testing for identity and strength. Homeopathic drugs in solid oral dosage form must have an
imprint that identifies the manufacturer and indicates that the drug is homeopathic. The imprint on
conventional products, unless specifically exempt, must identify the active ingredient and dosage
strength as well as the manufacturer.
Homeopathic drugs are not exempt from the provisions
of the Food, Drug, and Cosmetic Act. Matrixx Initiatives, Inc. claims that Zicam Cold Remedy
intranasal products" reduces" the "duration of the common cold" and the
"severity of cold symptoms," including specifically "sore throat o stuffy nose
osneezing o coughing o congestion." These claims make these products drugs, as defined by the
Food, Drug, and Cosmetic Act, because they are intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease or to affect the structure or function of the body of man or
Health professionals should counsel consumers on two points about Zicam and
homeopathic drugs. One, Zicam intranasal products should not be used because of the risk of
anosmia. Two, the safety and efficacy of homeopathic drugs have not been evaluated by the FDA based
on high quality randomized clinical trials.
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